Senior Specialist, Technical Service CMO (Contract Manufacturing Organization)
GlaxoSmithKline
Wavre, BE
4 dagen geleden
source : DirectEmployers Association

Job purpose : As Senior Specialist Technical Services for External Supply, you will : + Ensure, coordinate and support the manufacturing, technology and validation activities deployment for enabling External Supply (Supply & Quality Organizations) to deliver its strategic objectives as a Virtual Plant.

  • Be the expert and SPOC for any technical and validations topics.+ Ensure the continuous technical and validation life cycle support at the CMO's.
  • Lead complex Continuous Improvement project with supply and financial impacts on the GSK Vaccines business. Your responsibilities : + Based on the transversal project portfolio, you coordinate and support the overall activities deployment (routine operation, field, technical support, and validation) for primary & secondary processes, and escalate any issue+ You act as validation and technical Expert within External Supply (ES)+ You are the Single Metter Expert reference into the Manufacturing Expertise (MSAT)+ You define the validation strategy to apply at the CMO and also support the evaluation team during the Change control evaluation phase.
  • You manage validation lifecycle for the international CMO portfolio.+ You support CMO to establish all maintenance and requalification programs including the QC validation of equipment (IQOQ) and transversal equipment PQ (Autoclave, clean utilities, GMP washer, Incubators, thermostatic rooms,)+ You provide the adequate training support for technical related topics to the CMO, QA ES and Supplier Relationship Manager's if needed.
  • You define with the ES QA the adequate GMP standard for validation and technical topics integrating the local regulations+ You support CMO for audit documentation and inspection readiness and prepare the local team (dry run) during audits+ You lead using his expertise a transversal team in case of deviation and CAPA definition related to the technical field+ You support the CMO by frequent site visits, teleconference.
  • You ensure the availability of the all documentation required to support the validation+ You approve the cornerstone documents during the transversal projects+ You liaise with Engineering Shared Services when support is requested from partner's facility design or support for custom-designed process equipment+ You identify and escalate any potential risk in the context of risk management+ You support the ES QA and SRM's with the CMO Evaluation in regards to technical and validation expertise and compliance level Why You?
  • Basic qualifications : We are looking for professionals with these required skills to achieve our goals : + University degree in the Pharma and / or Biotechnology field with experience in manufacturing / primary & secondary operations of vaccines / Project Management (3 to 6 years)+ Scientific and technological know-how related to vaccine manufacturing operations.

  • Knowledge of international regulations (FDA, PIC's, WHO, Eudralex and local cGMP)+ Good knowledge of GSK Vx organization and inter relationships between all GSK Vx departments+ Stakeholder management (interaction with Quality, Regulatory and Manufacturing / QC experts)+ Fluent English written and spoken, any other language is an advantage+ Keep scientific and technological know-how updated.
  • Social skills to foster teamwork of people belonging to different organizations / departments / sites Preferred Qualifications : If you have the following characteristics it would be a plus : + Sense of urgency, flexibility and accountability+ Experience in working in matrix organization Why GSK?
  • Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

    GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages.

    We deliver over two million vaccine doses per day to people living in over 160 countries.For further information, please visit Our department : GIOOnce our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most.

    Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So, it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.

    As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.

    The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

    At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

    We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

  • Li-GSKIf you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
  • Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible.

    Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

    Important notice to Employment businesses / AgenciesGSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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